Regulatory Update: GSK Announces Submission for A New Indication for Synflorix in Europe

GlaxoSmithKline plc (GSK) announced today that it has submitted a
regulatory application in the European Union (EU) seeking approval
of an additional indication for Synflorix™, a paediatric
pneumococcal vaccine, for the active immunisation against pneumonia
caused by Streptococcus pneumoniae in infants and children from 6
weeks up to 5 years of age.

The application was submitted as a variation to the Marketing
Authorisation Application to the European Medicines Agency.

About Synflorix™
Synflorix™ is currently approved in the EU and 90 other
countries for active immunisation against invasive disease and
acute otitis media caused by Streptococcus pneumoniae in infants
and children from six weeks up to five years of age. Of these 90
countries, 67 already have the indication for pneumonia approved.
Synflorix™ is not approved for use in the US.

Important Safety Information

The most common adverse reactions observed after primary
vaccination with Synflorix™ in infants were redness at the
injection site and irritability. For more important safety
information about the currently licensed indications for Synflorix,
please visit Synflorix - Vaccines - Our products - GlaxoSmithKline
to view the Synflorix EU Patient Information Leaflet.

GlaxoSmithKline – one of the world’s leading
research-based pharmaceutical and healthcare companies – is
committed to improving the quality of human life by enabling people
to do more, feel better and live longer. For further information
please visit www.gsk.com

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